A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE) (ISLAND-SLE)

March 27, 2024 updated by: Nektar Therapeutics

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Study Type

Interventional

Enrollment (Actual)

291

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aire, Argentina, C1221ADC
        • Hospital J. M. Ramos Mejía
      • Córdoba, Argentina, 5004
        • Hospital Cordoba
      • San Juan, Argentina, J5402DIL
        • Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1111
        • DOM- Centro de Reumatologia
      • Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina, 1417
        • Centro Privado de Medicina Familiar / Mindout Research
    • Ciudad Autónoma De Buenos Aire
      • Caba, Ciudad Autónoma De Buenos Aire, Argentina, C1430EGF
        • Clinica Adventista Belgrano
      • Caba, Ciudad Autónoma De Buenos Aire, Argentina, 1406
        • APRILLUS Asistencia E Investigacion de Arcis Salud
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australia
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University Of Calgary
  • Czechia
    • Ostrava Město
      • Ostrava, Ostrava Město, Czechia, 70300
        • INREA s.r.o.
    • Praha, Hlavní Mešto
      • Praha 2, Praha, Hlavní Mešto, Czechia, 12850
        • Revmatologicky ustav
  • Germany
      • Kiel, Germany, 24105
        • Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Köln, Germany, 50924
        • Universitätsklinikum Köln
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitätsklinikum Tübingen
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44649
        • Rheumazentrum Ruhrgebiet
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universtitätsklinikum Essen AöR
    • Schleswig-Holstein
      • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
        • Klinikum Bad Bramstedt GmbH
  • Hungary
      • Budapest, Hungary, 1036
        • Qualiclinic
      • Debrecen, Hungary, 4004
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
    • Békés
      • Gyula, Békés, Hungary, 5700
        • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500003
        • Krishna Institute of Medical Science
      • Visakhapatanam, Andhra Pradesh, India, 530002
        • King George Hospital
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Amber Clinic
      • Ahmedabad, Gujarat, India, 380054
        • Swastik Rheumatology Clinic
    • Karnataka
      • Hubli, Karnataka, India, 580021
        • Sushruta Multispeciality Hospital & Research Centre
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431001
        • Government Medical College (GMC) Aurangabad
      • Nagpur, Maharashtra, India, 440003
        • Government Medical College
      • Nagpur, Maharashtra, India, 440012
        • Jasleen Hospital
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences - Nagpur
      • Pune, Maharashtra, India, 41005
        • Sancheti Institute for Orthopaedics & Rehabilitation
      • Pune, Maharashtra, India, 411001
        • Center for Rheumatic Diseases
      • Pune, Maharashtra, India, 411005
        • Sancheti HealthCare Academy
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • HaMerkaz
      • Ramat Gan, HaMerkaz, Israel, 5262100
        • Sheba Medical Center
  • Japan
      • Chiba, Japan, 260-8712
        • National Hospital Organization Chibahigashi National Hospital
      • Fukuoka, Japan, 810 8563
        • National Hospital Organization Kyushu Medical Center
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 543-0042
        • Daini Osaka Police Hospital
      • Tokyo, Japan, 104-8560
        • St. Luke's International Hospital
      • Tokyo, Japan, 160 8582
        • Keio university hospital
    • Aichi
      • Nagoya, Aichi, Japan, 4570818
        • Kojunkai Daido Clinic
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • University of Occupational and Enviromental Health
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Shinshu University Hospital
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital
  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Korea
      • Incheon, Korea, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Korea, Republic of, 04763
        • Hanyang University Medical Center
      • Seoul, Korea, Korea, Republic of, 02447
        • Kyung Hee University Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital
  • Mexico
    • Baja California
      • Mexicali, Baja California, Mexico, 21100
        • Centro Medico del Angel
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • CIMAB SA de CV
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 03100
        • RM Pharma Specialists S.A. de C.V.
      • Mexico City, Distrito Federal, Mexico, 06700
        • Clinica para el Diagnostico y Tratamiento de la Enfermedades
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Clinica de Investigacion en Reumatologia y Obesidad S. C.
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatología
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00874
        • MICS Centrum Medyczne Warszawa
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-707
        • Nova Reuma Społka Partnerska
    • Śląskie
      • Bytom, Śląskie, Poland, 41-902
        • Nzoz Bif-Med
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Centro Reumatologico Caguas
      • San Juan, Puerto Rico, 00918
        • Mindful Medical Research
      • San Juan, Puerto Rico, 00909
        • Latin Clinical Trial Center
      • San Juan, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Romania
      • Bucuresti, Romania, 011025
        • SC Centrul Medical Sana SRL
      • Bucuresti, Romania, 011172
        • Spitalul Clinic Sf Maria Bucuresti
      • Galati, Romania, 800578
        • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei
    • Brașov
      • Brasov, Brașov, Romania, 500283
        • C.M.D.T.A. Neomed
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • V.A. Nasonova Research Institute of Rheumatology
      • Ryazan, Russian Federation, 390026
        • Ryazan Regional Clinical Cardiology Dispensary
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russian Federation, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Moskva
      • Moscow, Moskva, Russian Federation, 111539
        • Moscow City Clinical Hospital Number 15
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Sevilla, Spain, 41010
        • Hospital Quiron Infanta Luisa
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Memorial Hospital - Kaohsiung Branch
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Taipei City, Taiwan, 10048
        • National Taiwan University Hospital
  • Ukraine
      • Kharkiv, Ukraine
        • Regional Clinical Hospital Center for Emergency medical care
      • Kyiv, Ukraine
        • Kyiv City Clinical Hospital #3
      • Kyiv, Ukraine, 02002
        • Edelweiss Medics LLC
      • Odesa, Ukraine, 65026
        • Multifield Medical Center of Odesa NMU (University Clinic#1)
      • Vinnytsya, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital
      • Zaporizhzhia, Ukraine, 69600
        • Regional Clinical Hospital of Zaporizhzhia
  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California - San Diego
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Stanford, California, United States, 94305
        • Stanford University Hospital
      • Upland, California, United States, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado School of Medicine
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Clinical Research Center of CT/NY
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Medicine
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
      • Miami, Florida, United States, 33165 3338
        • New Horizon Research Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • New York, New York, United States, 10016
        • NYU Langone
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5046
        • Oklahoma Medical Research Foundation
    • Texas
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research Center
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research
      • Sugar Land, Texas, United States, 77479
        • Fort Bend Clinical Research, LLC
    • Washington
      • Seattle, Washington, United States, 98195-6422
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
  • Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
  • Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
  • Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
  • Have a clinical SLEDAI-2K score ≥4 at randomization.
  • Have active arthritis and/or active rash.

Exclusion Criteria:

  • Have severe active lupus nephritis.
  • Have active central nervous system (CNS) lupus.
  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC
Experimental: LY3471851 High Dose
LY3471851 administered subcutaneously (SC).
Drug: LY3471851
Administered SC
Other Names:
  • NKTR-358
  • REZPEG
  • Rezpegaldesleukin
Experimental: LY3471851 Mid Dose
LY3471851 administered SC.
Drug: LY3471851
Administered SC
Other Names:
  • NKTR-358
  • REZPEG
  • Rezpegaldesleukin
Experimental: LY3471851 Low Dose
LY3471851 administered SC
Drug: LY3471851
Administered SC
Other Names:
  • NKTR-358
  • REZPEG
  • Rezpegaldesleukin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a ≥4 Point Reduction in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2000 (2K) Score at Week 24
Time Frame: Week 24
Percentage of Participants who Achieved a ≥4 Point Reduction in SLEDAI-2K Score at Week 24. A SLEDAI-4 response is defined as a ≥4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score from baseline. The SLEDAI-2K score range is from a minimum of 0 to a maximum of 105 (higher scores represent higher disease activity).
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved British Isles Lupus Assessment Group (BILAG) Based Composite Lupus Assessment (BICLA) Response at Week 24.
Time Frame: Week 24

Percentage of Participants who Achieve BICLA Response at Week 24. The BILAG-based Composite Lupus Assessment (BICLA) is a composite index used to assess disease activity in SLE. A BICLA response is defined as:

  • Reduction of all baseline BILAG-2004 A to B or C or D; and baseline BILAG-2004 B to C or D; and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B.
  • No worsening from baseline in SLEDAI-2K, where worsening is defined as any increase from baseline in SLEDAI-2K.
  • No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point PGA visual analogue scale (VAS).
Week 24
Percentage of Participants Who Achieved Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response at Week 24
Time Frame: Week 24
Percentage of Participants who Achieved a SRI-4 Response at Week 24. A SRI-4 response is defined as a decrease in SLEDAI-2K >= 4 from baseline. No new BILAG A and no more than 1 new BILAG B disease activity score / organ domain (both compared with baseline), and no worsening in PGA (defined as an increase of 0.3 points [10 mm] from baseline.
Week 24
Percentage of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) at Week 24
Time Frame: Week 24
Percentage of Participants who Achieved LLDAS at Week 24. A LLDAS response is defined as a low level of disease activity attained without use of low-dose steroids and/or standard-of-care immunosuppressant medications.
Week 24
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3471851
Time Frame: Week 24
LY3471851 plasma trough concentrations are the concentrations of drug in plasma immediately before the next dose is administered.
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nektar Therapeutics

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Study Director, Nektar Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

February 16, 2023

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17422
  • J1P-MC-KFAJ (Other Identifier: Eli Lilly and Company)
  • 2019-003323-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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